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Clinical Trial Details

Trial ID: L1327
Source ID: NCT02590081
Associated Drug: Dextrose 5%
Title: Effect of Sodium Rinsing Fluid on Blood Pressure and Interdialytic Weight Change in Hemodialysis Patients
Acronym: NSD5
Status: UNKNOWN
Study Results: NO
Results:
Conditions: End-Stage Kidney Disease|Hemodialysis
Interventions: DRUG: Dextrose 5%|DRUG: normal saline
Outcome Measures: Primary: systolic blood pressure control, post intervention systolic blood pressure reduction compared to baseline, Time from week 0 until week 12 | Secondary: Interdialytic weight gain, reduced Interdialytic weight gain in experimental group, Time from week 0 until week 12|thirst level, Dialysis thirst inventory questionnaire to be administer by patient at baseline (week 0) and end of trial (week 12), Time from week 0 and week 12|intradialytic event, Any incident occuring during hemodialysis treatment which needed medical intervention. The event are chills and rigor, chest pain, giddiness, cramps, vomiting, blood loss and hypotension., Time from week 0 until week 12|adverse events, All observed or spontaneously reported adverse events occur during the trial period., Time from week 0 until week 12
Sponsor/Collaborators: Sponsor: Penang Hospital, Malaysia | Collaborators: Ministry of Health, Malaysia
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 434
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose:
Start Date: 2015-10
Completion Date:
Results First Posted:
Last Update Posted: 2015-10-28
Locations: Hospital Sultanah Bahiyah, Alor Setar, Alor Setar, Kedah, 05460, Malaysia|Hospital Tuanku Jaafar, Seremban, Negeri Sembilan, 70300, Malaysia|Hospital Tengku Ampuan Afzan, Kuantan, Pahang, 25100, Malaysia|Hospital Balik Pulau, Balik Pulau, Penang, 11000, Malaysia|Hospital Bukit Mertajam, Bukit Mertajam, Penang, 14000, Malaysia|Penang Hospital, George Town, Penang, 10990, Malaysia|Hospital Kepala Batas, Kepala Batas, Penang, 13200, Malaysia|Seberang Jaya Hospital, Seberang Jaya, Penang, 13700, Malaysia|Hospital Sungai Bakap, Sungai Bakap, Penang, 14200, Malaysia|Miri Hospital, Miri, Sarawak, 98000, Malaysia|Selayang Hospital, Selayang, Selangor, 68100, Malaysia|Hospital Serdang, Serdang, Selangor, 43400, Malaysia|UKM Medical Centre, Cheras, Wilayah persekutuan Kuala lumpur, 56000, Malaysia|Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, 50586, Malaysia|UM Medical Centre, Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, 59100, Malaysia
URL: https://clinicaltrials.gov/show/NCT02590081